Dispas, Amandine, Guillarme, Davy, Hubert, Philippe, Clarke, Adrian and Grand-Guillaume-Perrenoud, Alexandre (2021) Interlaboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities: evaluation of multi-systems reproducibility. Journal of pharmaceutical and biomedical analysis, 203 (Articl). ISSN 07317085

Abstract

Modern Supercritical Fluid Chromatography (SFC) is now a well-established technique, especially in the field of pharmaceutical analysis. We recently demonstrated the transferability and the reproducibility of a SFC method for pharmaceutical impurities by means of an inter-laboratory study. However, as this study involved only one brand of SFC instrumentation, the present study extends the purpose to multi-instrumentations evaluation. In this context, three instrument types, namely Agilent®, Shimadzu®, Waters®, were included through 21 laboratories (n = 7 for each instrument). Firstly, method transfer was performed to assess the separation quality using these instruments and to set up the specific instrument parameters of Agilent® and Shimadzu® instruments. Secondly, the inter-laboratory study was performed following the protocol defined by the sending lab. Analytical results were deeply examined regarding consistencies within- and between-laboratories criteria. Afterwards, the method reproducibility was estimated taking into account variances in replicates, between-days and between-laboratories. Obviously, reproducibility variance was larger than that observed during the first study involving only one single type of instrumentation. Indeed, we clearly observed an ‘instrument type’ effect. Moreover, general speaking, the reproducibility variance was larger when considering all instruments than each type separately. The configuration of each modern SFC instrument easily explained the variability induced by the instrument. Nevertheless, repeatability and reproducibility variances were found to be similar than those described for LC methods (i.e. reproducibility RSD around 15%). These results highlighted the robustness and the interest of SFC to provide accurate results for pharmaceutical quality control analysis.

Item Type:	Article
Date Deposited:	07 Sep 2021 00:45
Last Modified:	07 Sep 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44739